a phase 2 study comparing 2 intermittent dosing schedules of duvelisib in participants with indolent non-hodgkin lymphoma

Conditions: Indolent Non-Hodgkin Lymphoma

Summary: this study examined the effects of predefined 2-week duvelisib dose holidays on tumor responses and safety/tolerability.

this was a phase 2, randomized, open-label, 2-arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in participants with relapsed or refractory (r/r) indolent non-hodgkin lymphoma (inhl) who have received at least 1 prior systemic therapy.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group performance status ≤ 2 * histologically confirmed diagnosis of inhl (subtypes include follicular lymphoma \[fl\] grades 1 to 3a), marginal zone lymphoma (splenic, nodal, or extranodal), or small lymphocytic lymphoma * must have received 1 prior systemic regimen for inhl * must have documented radiologic evidence of disease progression, at least 1 bi-dimensionally measurable lesion ≥ 1.5 centimeters (which has not been previously irradiated), according to 2007 revised international working group criteria, and be a candidate for a subsequent line of therapy. * must have adequate organ function defined by the following laboratory parameters: * absolute neutrophil count ≥ 1.0 × 10\^9/liter (l) * platelet count ≥ 75 × 10\^9/l * hemoglobin ≥ 8 grams/deciliter * estimated creatinine clearance ≥ 60 milliliters/minute, as determined by the cockcroft-gault method * total bilirubin ≤ 1.5 × upper limit of normal (uln) (exception: participants with gilbert's syndrome may have a bilirubin \> 1.5 × uln) * aspartate transaminase/serum glutamic-oxaloacetic transaminase and alanine aminotransferase/serum pyruvic transaminase ≤ 3.0 × uln exclusion criteria: * anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of study intervention; palliative radiation therapy is allowed if \> 7 days before planned first dose of study interventions, and any toxicity is grade ≤ 1 * clinical or histological evidence of transformation to a more aggressive subtype of lymphoma or grade 3b fl or richters' transformation or chronic lymphocytic leukemia * prior allogeneic hematopoietic stem cell transplant; prior treatment with a pi3k inhibitor * history of drug-induced colitis or pneumonitis; tuberculosis treatment ≤ 2 years prior to randomization; administration of a live or live attenuated vaccine within 6 weeks of randomization * ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection * active cytomegalovirus or epstein-barr virus infection * unable to receive prophylactic treatment for pneumocystis, herpes simplex virus, or herpes zoster at screening * concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3a. no prior use within 2 weeks before the start of study intervention. * baseline qt interval corrected with fridericia's method \> 500 milliseconds * concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. participants with previous malignancies are eligible if they have been disease-free for 2 years or more. * unstable or severe uncontrolled medical condition that would, in the investigator's judgment, increase the participant's risk to participating in this study.

Keywords: pi3k inhibitor